Domestic drugs dominate the market, with a growth rate of 45%... A closer look at 30 billion key varieties of anti dementia drugs in the market

Medical Network September 25 September 21 is world Alzheimer's day Data from 2017 Alzheimer's disease facts and figures show that there were 5.5 million Alzheimer's disease (AD) patients in the U.S in 2017, an increase of 1.85% over the previous year, of which early-onset AD patients accounted for about 4% The annual cost of dementia in the United States has exceeded US $259 billion After the global aging society, the number of patients with dementia is increasing, but human beings can't do anything about this kind of disease According to the statistics of world ad report, there are 46.8 million patients with dementia in the world, which has become one of the challenges in the field of human medicine and a huge opportunity for the development of global medicine Global market at home and abroad: only 6 therapeutic drugs have been approved for more than 20 years In the past 20 years, the U.S FDA has only approved six drugs for Alzheimer's disease treatment, namely: tacrine approved in 1993, donepezil approved in 1996, rivastigmine approved in 2000, galantamine approved in 2001, memantine approved in 2003, and US dollar approved on December 24, 2014 The compound preparation of gondolepezil (namzaric) Among the above drugs, the first four are cholinesterase (AChE) inhibitors, and memantine is NMDA receptor antagonist These drugs can only control or improve cognitive and functional symptoms for 6 to 12 months, and can not prevent or significantly delay the further development of the disease The global ad drug research and development line has always been moving forward, but the result seems to be a drop in the bucket As of August 2018, the number of new chemical and molecular drugs for AD treatment approved by FDA in the past 10 years is very small, only three ad diagnostic drugs have been approved, namely: amyvid, a diagnostic drug approved by Lilly in 2012; vizamyl, a diagnostic radioactive drug approved by medi physics general medical company in 2013; flurbital, an Indian pharmaceutical company, approved by Piramal imaging company in 2014 Class (neuroceq) diagnostic reagent Under the situation of patent drug expiration, generic drug listing and lack of new drugs, the global ad original research drug market in 2017 was only about 4 billion US dollars, showing a slow decline year by year Domestic: the relevant market has exceeded 30 billion yuan At present, the awareness rate and treatment improvement rate of domestic ad have been improved, thus promoting the continuous growth of this market According to the data of minenet database, the amount of anti AD and anti Alzheimer's drugs used by sample hospitals in key cities in 2017 was 6.528 billion yuan, an increase of 5.09% over the previous year There are more than 20 kinds of commonly used drugs and auxiliary drugs The amount of top 10 drugs reached 6.2 billion yuan, an increase of 9.30% over the previous year The top 10 drug competition pattern was: ganglioside accounted for 27.51%, oxiracetam 23.50%, rat nerve growth factor 14.37%, brain glycoside and inosine peptide 10.40%, citicoline 7.54%, vinpocetine 6.87%, Gu Hong 3.08%, donepezil 2.95%, memantine 1.91%, brain egg white hydrolysate 1.88% In fact, the domestic market of anti AD and improvement of senile dementia memory has exceeded 30 billion yuan Key varieties of memantine: Memantine, the only anti AD drug in TOP400, is a non competitive NMDA receptor antagonist with voltage dependence and medium affinity, and is also the first drug used to treat moderate and severe Alzheimer's disease In 1986, memantine entered the clinical trial as a dementia treatment drug, which was officially launched in Germany in 1989, under the trade name of axura Subsequently, the NMDA receptor inhibition of memantine was confirmed The German company Merz and American forest company launched clinical trials to treat Alzheimer's disease and other central nervous system diseases At the same time, Danish Lingbei company participated in the cooperation and transferred the drug In February 2002, the European Patent and Drug Commission (CPMP) approved memantine hydrochloride from Lingbei company of Denmark for the treatment of patients with moderate and severe Alzheimer's disease, under the trade name of ebixa On October 17, 2003, the US FDA approved the memantine of forest company with the trade name of namenda Memantine is the only anti AD drug among the top 400 global sales in 2017 With sales of 453 million US dollars, Aerjian's namenda is still the main product in the anti AD drug market In 2006, memantine from Lingbei pharmaceutical company of Denmark entered the Chinese market under the trade name of ebyshen On July 16, 2013, the drug regulatory department of China approved the listing of memantine APIs, tablets and oral solutions of Zhuhai United Pharmaceutical Co., Ltd under the trade name of yibeiqing In July 2017, memantine APIs of shangyujing new pharmaceutical and Hunan Dongting pharmaceutical were approved for production Data shows that in 2017, the purchase amount of memantine in the public sample hospitals in key cities in China was 118 million yuan, an increase of 20.05% over the previous year The main varieties on the market are yibeishen and yibeiqing, of which the original research drug yibeishen accounts for more than 90% Memantine can be combined with the cholinesterase inhibitors donepezil, huperzine A, galanthamine hydrobromide and carbamate bitartrate to enhance the therapeutic effect Oxiracetam: a leader in the domestic market, oxiracetam is the new generation of brain metabolism improvement drug exclusive to domestic drugs, which belongs to the ring derivative of r-aminobutyric acid It was first synthesized by Italy's scobechem company, and went on the market in 1987 Oxiracetam is an analogue of piracetam, which can promote the synthesis of phosphorylcholine and phosphorylethanolamine, increase the ratio of ATP / ADP in brain cells, increase the synthesis of protein and nucleic acid in brain, enhance the conduction of nerve excitation, and improve the senile memory dysfunction The dosage forms approved by China's drug regulatory authorities for listing include injection, powder injection and oral capsule According to the data, in 2017, the amount of drug use of oxiracetam, a public sample hospital in key cities in China, was 1.455 billion yuan, an increase of 22.06% over the previous year The study shows that olacetam has higher pharmacological activity and significant clinical effect than piracetam The adverse reactions of olacetam are less, the occasional symptoms are lighter, and it can recover by itself Olacetam is in the leading position in the domestic market of improving intelligent barrier drugs, and the market is dominated by domestic drugs In the first half of 2018, it ranked 13th in the top 20 drugs of public sample hospitals in key cities in China The leading drugs in the market of oxiracetam are: beiqingxing injection of oxiracetam of Guangdong Shixin Pharmaceutical Co., Ltd., Ouyi pharmaceutical capsule and powder injection of oulaining group and Oulan injection of Harbin Sanlian Pharmaceutical Co., Ltd In addition, the products of Hunan Jianlang pharmaceutical industry also occupy a certain market Donepezil: the global market has declined, and the domestic market has steadily increased Donepezil is a highly selective and reversible drug for the treatment of AD, which is the second generation of central acetylcholinesterase inhibitor According to the hypothesis of β - amyloid, the deposition of β - amyloid in cerebral cortex and the formation of senile plaques are the important reasons of AD, and acetylcholine receptor is closely related to the formation of β - amyloid Donepezil was developed by Japan's WaMu Pharmaceutical Co., Ltd and was licensed by the U.S FDA for clinical use on November 25, 1996 Its trade name is Aricept Japan's WaMu and U.S Pfizer jointly develop the global market At the peak of the global donepezil market, the sales in 2010 exceeded US $4 billion, and after the expiration of the patent, the sales decreased year by year In 2017, the sales was only about RMB 100 million Donepezil is the second drug approved by the FDA for the treatment of Alzheimer's disease It has been recognized by the medical community at home and abroad for its small dosage and low toxic and side effects, and good tolerance is its biggest advantage In October 1999, donepezil was listed in China under the trade name of "Allison" At present, China's drug regulatory department has approved 13 enterprises to produce donepezil preparations, the main dosage forms are tablets, capsules, dispersible tablets, orally disintegrating tablets, etc The main manufacturers selling in the domestic market are Weicai (China) pharmaceutical, Jiangsu Haosen pharmaceutical, Chongqing Zhien pharmaceutical, Shaanxi Fangzhou pharmaceutical, Shandong Luoxin pharmaceutical, Xi'an Haixin pharmaceutical, Guizhou shengjitang pharmaceutical, Yangzijiang Pharmaceutical Group Shanghai haini pharmaceutical, Tianjin Lisheng pharmaceutical, Shandong Zibo Xinda pharmaceutical, Xiamen Jinri pharmaceutical, Shandong Fangming pharmaceutical, Furen Pharmaceutical Group, etc , the main trade names are Allison, Ares, sarinx, norchong, Gucci, fusk, geffer, sibohai, etc Clinical studies have shown that donepezil has a specific selectivity in the action of ache in brain and little effect on human transaminase 95% of drugs combined with plasma protein are metabolized by cytochrome P450 system, which can significantly improve many patients with mild and moderate ad Donepezil is a drug entering the national medical insurance catalogue, which is good for patients and enterprises, and will promote the future market Data shows that in 2017, the amount of donepezil used in public sample hospitals in key cities in China was 183 million yuan, an increase of 18.22% over the previous year The top three drugs in the drug market of the sample hospitals are an Lishen of Weicai, shilop of Haosen in Jiangsu and ares of Fangzhou in Shaanxi Citicoline: more than 200 approvals, with a good growth rate Citicoline is the activator of brain metabolism and the derivative of nucleic acid It is the main coenzyme for the synthesis of ovosphate ester It can promote brain cell respiration, improve brain function, enhance the function of ascending reticular structure activation system, promote recovery, reduce cerebrovascular resistance, thus improve cerebral blood circulation, cerebral hypoxia and brain material metabolism It is an important component in the construction of human biomembrane It is mainly used to treat neurological sequelae caused by brain injury and cerebrovascular accident Citicoline is a general drug with low price It has been used in China for more than 20 years So far, more than 200 production registration documents have been issued The dosage forms include granules, enteric coated capsules, enteric coated tablets, chewing tablets and dispersive tablets Because oral medicine can maintain a relatively stable blood concentration, especially citicoline oral medicine can be used in the outpatient department of Neurology for its convenience and safety, so it is conducive to the clinical promotion of the product Data shows that in 2017, the amount of citicoline used in public sample hospitals in key cities in China was 467 million yuan, an increase of 45.55% over the previous year, with a high growth rate